Reproducibility of the Measurement of the Right Portal Vein Diameter

NCT ID: NCT04617964

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-07-01

Brief Summary

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Although routine ultrasound is offered during the third trimester of pregnancy, less than a quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally.

The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses.

However, to our knowledge, the only interoperator reproducibility study of this measurement was performed using the same stored images or datasets without performing a new examination.

The main objective of this study is to assess the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound.

The secondary objective is to quantify the interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid.

Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.

Detailed Description

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Conditions

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Intrauterine Growth Retardation (IUGR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IUGR

sample of 40 pregnant women affected by intrauterine growth restriction (IUGR) Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.

Ultrasound

Intervention Type OTHER

Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

NORMAL

Ssample of 40 healthy pregnant women Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.

Ultrasound

Intervention Type OTHER

Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

Interventions

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Ultrasound

Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

Intervention Type OTHER

Other Intervention Names

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Third trimester ultrasound

Eligibility Criteria

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Inclusion Criteria

* Women carrying a pregnancy from 30 weeks to 33 weeks either normal or with IUGR,
* Patient without guardianship or curatorship or subordination,
* Patient benefiting from a Social Security scheme

Exclusion Criteria

* Presence of a fetal malformation,
* Multiple pregnancy,
* Premature rupture of membranes,
* History of bariatric surgery,
* Body mass index (BMI)\> 30 kg / m2,
* Patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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C.H.U. de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2020- A01910-39

Identifier Type: -

Identifier Source: org_study_id

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